EUCTR2009-014351-72-SK进行中（未招募）1 期
A single-center, randomized, single-blind study in parallel groups to evaluate the efficacy and safety of a new intravenous iron HES preparation as compared to intravenous iron dextran (Cosmofer®) in EPO (erythropoietin) naïve patients suffering from anemia
Serumwerk Bernburg0 个研究点目标入组 50 人开始时间: 2010年9月8日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •5.1 Inclusion criteria
- •Patients eligible for inclusion in this study have to fulfill all of the following criteria:
- •1. Patients suffering from anemia (females with a hemoglobin in the range from 9-12 g/dl and males in the range
- •from 9-13,5 g/dl).
- •2. Age in the range of 18-75 years inclusive at visit 2 (baseline).
- •3. Patients suffering from CKD for at least six months
- •4. Females of child bearing potential with a safe method of contraception for the full study period
- •5. Patients must give written informed consent before any study specific assessment is performed.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •5.2 Exclusion criteria
- •A patient must not be recruited in this study if at least one single criterion of the subsequent list os fulfilled:
- •1. Females of child bearing potential without a safe method of contraception for the full study period
- •2. Pregnant or nursing (lactating) women
- •3. no EPO therapy during the last three months
- •4. inpatients for any reason
- •5. acute or chronic intoxication
- •6. renal failures in traumatic patients
- •7. any exclusion criteria from the CosmoFer SPC:
- •anemia caused by non-iron deficiency
- •iron overload
- •disturbances in iron metabolism
- •excess iron
- •atopic allergies
- •rheumatoid arthritis, acute phase of SLE
- •severe liver disease ALT/AST > 4 time UNL
- •severe infections
- •8. severe drug abuse
- •9. end stage renal disease
- •10. blood transfusions during the last six months
- •11. HbA1c>7,5%
- •12. anticipated medical need for EPO (erythropoietin) treatment during the main study period from baseline to the
- •day 7 (visit 3) or during three months prior the baseline visit.
- •13. Potentially unreliable patients, and those judged by the investigator to be unsuitable for the study.
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